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Author: Joaquim Vives
Publisher: Academic Press
ISBN: 0128031166
Category : Technology & Engineering
Languages : en
Pages : 279
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Book Description
Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. - Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge - Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data - Includes practical examples of successful implementation of quality standards
Author: Joaquim Vives
Publisher: Academic Press
ISBN: 0128031166
Category : Technology & Engineering
Languages : en
Pages : 279
Get Book Here
Book Description
Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. - Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge - Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data - Includes practical examples of successful implementation of quality standards
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Author: Luis Romero
Publisher: Createspace Independent Publishing Platform
ISBN: 9781985890183
Category :
Languages : en
Pages : 354
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Book Description
The book is about you.Traditional healthcare sometimes doesn't respond to specific needs and thus you may feel the need to explore & find a way to improve your quality of life. When you have a simple flu or a minor infection, following the rules of your local health system, your insurance procedures, or friends advice might not work. It's time to take responsibility over your own health. Even if it means getting educated on overseas options, emerging techniques and groundbreaking research.This book explains, in a simple language, the scope of Stem Cell therapies, the realistic expectations, as well as different forms of SCT, so that you can make an informed decision if this type of therapy is right for you.
Author: Daniel W. Lee
Publisher: Elsevier Health Sciences
ISBN: 9780323661812
Category : Medical
Languages : en
Pages : 0
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Book Description
From patient referral to post-therapy management, Chimeric Antigen Receptor (CAR) T-Cell Therapies for Cancer: A Practical Guide presents a comprehensive view of CAR modified T-cells in a concise and practical format. Providing authoritative guidance on the implementation and management of CAR T-cell therapy from Drs. Daniel W. Lee and Nirali N. Shah, this clinical resource keeps you up to date on the latest developments in this rapidly evolving area. Covers all clinical aspects, including patient referral, toxicities management, comorbidities, bridging therapy, post-CAR monitoring, and multidisciplinary approaches to supportive care. Includes key topics on associated toxicities such as predictive biomarkers, infections, and multidisciplinary approaches to supportive care. Presents current knowledge on FDA approved CAR T-cell products as well as developments on the horizon. Editors and authors represent leading investigators in academia and worldwide pioneers of CAR therapy.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 27
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Book Description
Author: Mahmoud Aljurf
Publisher: Springer Nature
ISBN: 3030644928
Category : Medical
Languages : en
Pages : 181
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Book Description
This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.
Author: Maria Cristina Galli
Publisher: Springer
ISBN: 3319186183
Category : Medical
Languages : en
Pages : 235
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Book Description
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Author: Christopher M. Hayre
Publisher: CRC Press
ISBN: 1000454347
Category : Medical
Languages : en
Pages : 193
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Book Description
This book provides an holistic picture of the application of research in radiography and focuses on multivariant methodological approaches and practices. It will provide readers insight into both contemporary and innovative methods within radiography research, backed up with evidence-based literature. This book may also be translated into other health disciplines as it introduces research to the reader by detailing terms that can often be confusing for students. These remain central in understanding the importance of research in radiography and how the generation of new knowledge is obtained. This will be supported with subsequent chapters concerning the literature, formation of research questions and detail the early beginnings of a research proposal. Chapters will include a wide range of topics, such as quantitative and qualitative methodologies and data collection tools pertinent to radiographic research, whilst discussing data analysis and need for rigor. The authors draw from our experiences, published outputs and clinical work, supported with alternate philosophies and methods used in diagnostic radiography. Each chapter will examine the multifaceted use and application of each ‘sub-theme’ pertinent to research in radiography, which is presented in a single text for students and, perhaps, practitioners. The targeted audience for this book is interdisciplinary but clearly focuses on those studying undergraduate radiography in response to the limited texts available. We also anticipate it to provide a useful tool for academics delivering undergraduate radiography programmes and those supporting postgraduate research. The key features will: • explore important research approaches and concepts within diagnostic radiography • provide contemporary evidence-based practice regarding mixed method approaches • provide a ‘how to guide’ for understanding key research principles in a wide range of radiographic settings • evaluate the impact of research on patients and the radiographer–patient relationship Dr. Christopher Hayre is a Senior Lecturer in Diagnostic Radiography at Charles Sturt University in New South Wales, Australia. Dr. Xiaoming Zheng has been teaching medical radiation science courses at Charles Sturt University since 1998.
Author: Minal Ghante
Publisher: Springer Nature
ISBN: 9819992710
Category :
Languages : en
Pages : 525
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Book Description
Author: Jorge S. Burns
Publisher: Springer Nature
ISBN: 3031300408
Category : Science
Languages : en
Pages : 226
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Book Description
This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental evaluations that critically influence stem cell regenerative medicine. Developing potency assays for cell-based medicinal products comes with numerous challenges due to the highly specialised nature of the application and purpose. This book provides the reader with the knowledge necessary to understand issues governing the successful development of potency assays, highlighting an international outlook of how the various challenges raised are being managed. Stakeholders concerned with potency assay development range from patient and clinician to contract research organisations, small and medium enterprise, regulatory authorities and even politicians. The value of potency assays is poised to increase given the inevitable watershed as early-stage clinical trials addressing safety progress to trials testing efficacy. Contributors from clinical, academic, industrial and regulatory sectors establish a broad point of view for guidance and timely debate. Potency assays require extensive collaboration across disciplines and sectors, as well as compromise and the authors aim to constructively address the many key aspects involved. Potency assays provide a quantitative measure of the biological activity of advanced therapy medicinal products (ATMPs) and thus are required for their market authorization. As the pace of ATMP development accelerates, the need to develop specific, accurate, and robust potency assays for each product is also accelerating. The volume Potency Assays for Stem Cell Advanced Therapy Medicinal Products presents a broad outlook on the development, quality attributes, and implementation of potency assays for ATMPs. The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potency assay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval. Subsequent chapters highlight efforts to develop potency assays for specific ATMPs, including skeletal stem cells, mesenchymal stromal cells, extracellular vesicles, CAR T-cells, and discuss emerging technologies/platforms for potency assay design. The volume concludes with a chapter reviewing potency assays used for the release of commercial ATMP products, which amalgamates information contained in previous chapters. Overall, the knowledge contributed from leading authorities in both academia and industry is an ideal resource for technicians, scientists, clinicians, process engineers, and regulators working with ATMPs. —Donald G. Phinney, PhD Professor, Department of Molecular Medicine, Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology
